News & Analysis as of

Group Purchasing Organizations

Wiley Rein LLP

Contracting With PBMs: Critical High-Value Issues to Consider

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Crafting a new pharmacy benefit manager (PBM) agreement may feel like an uphill battle when you do not have the time and resources to develop a highly customized contract. While it is often more beneficial to a health plan to...more

Mintz - Health Care Viewpoints

Senate HELP Committee Eyes Drug Pricing and PBM Regulation Beyond Federal Programs

On April 25, 2023, the Senate Health, Education, Labor, and Pensions Committee Chairman Bernie Sanders and Ranking Member Bill Cassidy introduced a package of legislation aimed at lowering prescription drug prices. The...more

Holland & Knight LLP

Healthcare Law Update: September 2018

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Regulation - CMS Contemplating Telemedicine Changes - The Centers for Medicare & Medicaid Services (CMS) recently published what it described as a "major proposed rule" that covers a number of topics that could have...more

Mintz

FTC Hosts Workshop – “Understanding Competition in Prescription Drug Markets: Entry and Supply Chain Dynamics”

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On Wednesday, November 8, 2017 the Federal Trade Commission (FTC) hosted a workshop seeking to explore the general question of why the cost of prescription drugs has risen greatly in recent history. The Workshop was framed...more

Mintz - Health Care Viewpoints

Six Key Follow-Up Questions Asked by Congress in 340B Hearing

Earlier this month the House Energy and Commerce Committee’s subcommittee on Government Oversight and Investigations held its second hearing on the 340B Drug Discount Program. The hearing followed on the heels of a July 18th...more

Baker Donelson

OIG Approves Wholly Owned Group Purchasing Organization

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In Advisory Opinion 16-06, the Office of Inspector General (OIG) approved a proposal whereby the ownership of a group purchasing organization (GPO) would be restructured so that the GPO will be wholly owned by the same...more

Holland & Knight LLP

OIG Issues Favorable Advisory Opinion Regarding Wholly Owned GPO Arrangement

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The U.S. Department of Health and Human Services Office of Inspector General (OIG) on May 9, 2016, issued Advisory Opinion 16-06, finding a sufficiently low level of risk in a group purchasing organization (GPO) arrangement...more

Arnall Golden Gregory LLP

OIG Issues Favorable Advisory Opinion Regarding Proposed Ownership Structure of Group Purchasing Organization

On May 2, 2016, the Department of Health and Human Services (HHS), Office of Inspector General (OIG) issued a favorable advisory opinion regarding a proposed arrangement, under which a group purchasing organization (GPO)...more

Mintz - Health Care Viewpoints

OIG Issues Favorable GPO Advisory Opinion

The OIG recently issued a favorable advisory opinion permitting a health system (the “Health System”) to become the sole owner of a Group Purchasing Organization (“GPO”), some of whose members were also owned by the Health...more

Cooley LLP

Blog: CMS Releases Improved Open Payments Website, Refreshed Open Payments Data

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The Centers for Medicare & Medicaid Services (CMS) announced today that it had released an improved Open Payments website. The website has been enhanced with a homepage tool for searching by doctor name, a “snapshot” of Open...more

Polsinelli

Orphan Drug Ruling Disrupts the 340B Program

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On Wednesday, the United States District Court for the District of Columbia issued its highly anticipated opinion regarding the 340B orphan drug litigation. The Court ruled in favor of PhRMA, a trade association that...more

Robinson & Cole LLP

Health Law Pulse - October 2015

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The Health Resources and Services Administration (HRSA) recently issued proposed omnibus guidance (Omnibus Guidance) interpreting various provisions of the 340B Drug Pricing Program (340B Program). The 340B Program allows...more

Polsinelli

Summary of Key 340B Omnibus Guidance Proposals

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As noted in our previous client alert, the Health Resources and Services Administration (“HRSA”) released its highly anticipated proposed 340B Drug Pricing Program Omnibus Guidance (“Guidance”). The Guidance offers updated...more

BakerHostetler

340B Guidance: Eight Key Points Covered Entities Should Consider

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On August 27, 2015, the Health Resources and Services Administration (HRSA), an agency of the U.S. Department of Health and Human Services (HHS), released the 340B Drug Pricing Program Omnibus Guidance (Guidance). Referred to...more

King & Spalding

HRSA Publishes Proposed 340B Drug Pricing Program Omnibus Guidance - Comments Due to HRSA on or before Tuesday, October 27, 2015

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On Friday, August 28, 2015, the Health Resources and Services Administration (“HRSA” or “the Agency”) published in the Federal Register Notice of its proposed “omnibus” or “mega” guidance (“Proposed Guidance”) regarding...more

K&L Gates LLP

HRSA Issues 340B Program Omnibus Guidance

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On August 28, 2015, the Health Resources and Services Administration (“HRSA”) published proposed Omnibus Guidance (the “Proposed Guidance”) governing policies related to section 340B of the Public Health Service Act (“PHSA”),...more

Baker Donelson

HRSA Issues Long-Awaited 340B Program Omnibus Guidance Proposal

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After much anticipation, the Health Resources and Services Administration (HRSA) late last week released its 340B Drug Pricing Program Omnibus Guidance Proposal (the Proposal). HRSA indicates that its goal in issuing the...more

King & Spalding

Omnibus Proposed Guidance Released for 340B Drug Pricing Program

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Last week, the Health Resources and Services Administration (HRSA), part of HHS, released proposed new guidance for covered entities enrolled in the 340B Drug Pricing Program, as well as drug manufacturers required to make...more

McDermott Will & Emery

HHS Releases Long-Awaited 340B Proposed Guidance

In August 27, 2015, the U.S. Department of Health and Human Services (HHS) released the long-awaited and much-anticipated proposed 340B Drug Pricing Program (340B Program) Omnibus Guidance (Proposed Guidance). The Proposed...more

King & Spalding

CMS Open Payment Program Data Indicates $6.49 Billion Paid by Manufacturers, GPOs to Physicians and Hospitals in 2014

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CMS recently released data collected through the Open Payments Program in accordance with the Affordable Care Act from applicable manufacturers and group purchasing organizations (GPOs) about payments and other transfers that...more

Cooley LLP

Blog: CMS’ Annual Open Payments Report to Congress Highlights Some Key Areas to Watch

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The Centers for Medicare & Medicaid Services (CMS) must submit an annual report to Congress in connection with the federal Sunshine law. ...more

Cooley LLP

Blog: CMS Issues Additional Sunshine FAQs

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The Centers for Medicare & Medicaid Services (CMS) released this week 5 new frequently asked questions (FAQs) related to reporting payments and transfers of value provided by applicable manufacturers and group purchasing...more

Mintz - Health Care Viewpoints

GPO Fees Under Scrutiny by the GAO

Last week, the Government Accountability Office (GAO) released a report examining group purchasing organization (GPO) practices. The GAO questioned whether the current structure of GPO funding through administrative fees is...more

Faegre Drinker Biddle & Reath LLP

GAO Takes Aim at GPOs

The GAO had drawn a bead on GPOs. In a report issued yesterday the Government Accountability Office expressed concern over the effect of GPOs (group purchasing organizations) on Medicare rates. The report recommended that...more

King & Spalding

CMS Will Refresh Sunshine Act Data by December 31, 2014

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During the 15th Annual Pharmaceutical Compliance Congress and Best Practices Forum on November 4, 2014, Douglas Brown, Deputy Director of the Data Sharing & Partnership Group within CMS’s Center for Program Integrity,...more

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